Trial Outcomes & Findings for A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab (NCT NCT04878211)

Last Updated: 2025-05-16

Results Overview

An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1

Results posted on

2025-05-16

Participant Flow

There were 24 participants screened. Cohort = C

Participant milestones

Participant milestones
Measure	C1: VN - Plan to Start OMB157 Vaccine naive, planning to start ofatumumab	C2: VN - on OMB157 >=4 WKs Vaccine naive, currently on ofatumumab for ≥ 4 weeks	C4: FV - OMB157 >=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster
Overall Study STARTED	5	2	1	11	5
Overall Study COMPLETED	4	2	0	1	0
Overall Study NOT COMPLETED	1	0	1	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	C1: VN - Plan to Start OMB157 Vaccine naive, planning to start ofatumumab	C4: FV - OMB157 >=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster
Overall Study Lost to Follow-up	0	1	0	1
Overall Study Protocol deviation	1	0	0	0
Overall Study Study terminated by sponsor	0	0	9	4
Overall Study Subject decision	0	0	1	0

Baseline Characteristics

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C1: VN - Plan to Start OMB157 n=5 Participants Vaccine naive, planning to start ofatumumab	C2: VN - on OMB157 >=4 WKs n=2 Participants Vaccine naive, currently on ofatumumab for ≥ 4 weeks	C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	C4: FV - OMB157 >=4 WKs n=1 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs n=11 Participants Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster n=5 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants	5 Participants n=8 Participants	24 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=8 Participants	19 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	2 Participants n=7 Participants	—	1 Participants n=4 Participants	10 Participants n=21 Participants	4 Participants n=8 Participants	20 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1

Population: Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry. Overall number analyzed included participants who received full course of vaccine (2 doses. n =number of participants with a positive result (responders). M = number of participants in the safety analysis set who received full course (2 doses) of a COVID 19 vaccine, including a COVID-19 booster for Cohort 6 participants

Outcome measures

Outcome measures
Measure	C1: VN - Plan to Start OMB157 n=5 Participants Vaccine naive, planning to start ofatumumab	C2: VN - on OMB157 >=4 WKs n=2 Participants Vaccine naive, currently on ofatumumab for ≥ 4 weeks	C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	C4: FV - OMB157 >=4 WKs n=1 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs n=11 Participants Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster n=5 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster	Overall n=24 Participants All cohorts
Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 15.8 to 100.0	—	0.0 Percentage of participants Interval 0.0 to 97.5	100.0 Percentage of participants Interval 69.2 to 100.0	50.0 Percentage of participants Interval 6.8 to 93.2	86.4 Percentage of participants Interval 65.1 to 97.1

SECONDARY outcome

Timeframe: Vaccination up to 70, 180, 270 and 360 days

Population: Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry)

Outcome measures

Outcome measures
Measure	C1: VN - Plan to Start OMB157 n=5 Participants Vaccine naive, planning to start ofatumumab	C2: VN - on OMB157 >=4 WKs n=2 Participants Vaccine naive, currently on ofatumumab for ≥ 4 weeks	C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	C4: FV - OMB157 >=4 WKs n=1 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs n=11 Participants Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster n=5 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster	Overall n=24 Participants All cohorts
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) 270 days post-vaccination n=5,2,0,1,10,4,22	60.0 Percentage of participants Interval 14.7 to 94.7	0.0 Percentage of participants Interval 0.0 to 70.8	—	0.0 Percentage of participants Interval 0.0 to 97.5	60.0 Percentage of participants Interval 26.2 to 87.8	50.0 Percentage of participants Interval 6.8 to 93.2	50.0 Percentage of participants Interval 28.2 to 71.8
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) 70 days post-vaccination n=5,0,0,0,0,0,5	100.0 Percentage of participants Interval 47.8 to 100.0	—	—	—	—	—	100.0 Percentage of participants Interval 47.8 to 100.0
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) 180 days post-vaccination, n=5,2,0,1,10,4,22	80.0 Percentage of participants Interval 28.4 to 99.5	0.0 Percentage of participants Interval 0.0 to 84.2	—	100.0 Percentage of participants Interval 2.5 to 100.0	90.0 Percentage of participants Interval 55.5 to 99.7	25.0 Percentage of participants Interval 0.6 to 80.6	68.2 Percentage of participants Interval 45.1 to 86.1
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) 360 days post-vaccination n=5,2,0,1, 10, 4,22	60.0 Percentage of participants Interval 14.7 to 94.7	0.0 Percentage of participants Interval 0.0 to 84.2	—	0.0 Percentage of participants Interval 0.0 to 97.5	10.0 Percentage of participants Interval 0.3 to 44.5	0.0 Percentage of participants Interval 0.0 to 60.2	18.2 Percentage of participants Interval 5.2 to 40.3

SECONDARY outcome

Timeframe: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1

Population: Safety analysis set

Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination.

Outcome measures

Outcome measures
Measure	C1: VN - Plan to Start OMB157 n=5 Participants Vaccine naive, planning to start ofatumumab	C2: VN - on OMB157 >=4 WKs n=2 Participants Vaccine naive, currently on ofatumumab for ≥ 4 weeks	C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	C4: FV - OMB157 >=4 WKs n=1 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	C5: FV - INFy or GA >=4 WKs n=11 Participants Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	C6: FV - on OMB157 >=4 WKs + Booster n=19 Participants Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster	Overall All cohorts
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) Pre-vac absence and post vac positive n=5,2, 0,0,0,7	80.0 Percentage of participants Interval 28.4 to 99.5	50.0 Percentage of participants Interval 1.3 to 98.7	—	—	—	71.4 Percentage of participants Interval 29.0 to 96.3	—
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) Pre-vac presence and post vac ≥4-fold increase n=5,2,0,0,0,7	0 Percentage of participants Interval 0.0 to 52.2	0.0 Percentage of participants Interval 0.0 to 84.2	—	—	—	0.0 Percentage of participants Interval 0.0 to 41.0	—
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) Initial negative SARS nucleocapsid with post-vac positive SARS n=0,0,0,1,1,2	—	—	—	0.0 Percentage of participants Interval 0.0 to 97.5	0.0 Percentage of participants Interval 0.0 to 97.5	0.0 Percentage of participants Interval 0.0 to 84.2	—
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) Immune conversion n=5,2,0,1,1,9	80.0 Percentage of participants Interval 28.4 to 99.5	50.0 Percentage of participants Interval 1.3 to 98.7	—	0.0 Percentage of participants Interval 0.0 to 97.5	0.0 Percentage of participants Interval 0.0 to 97.5	55.6 Percentage of participants Interval 21.2 to 86.3	—

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 5

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 6

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=5 participants at risk C1: VN - plan to start OMB157 Vaccine naive, planning to start ofatumumab	Cohort 2 n=2 participants at risk C2: VN - on OMB157 \>=4 WKs Vaccine naive, currently on ofatumumab for ≥ 4 weeks	Cohort 3 C3: VN - INFy or GA \>=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	Cohort 4 n=1 participants at risk C4: FV - OMB157 \>=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	Cohort 5 n=11 participants at risk C5: FV - INFy or GA \>=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	Cohort 6 n=5 participants at risk C6: FV - on OMB157 \>=4 WKs + booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster
Injury, poisoning and procedural complications Foot fracture	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	9.1% 1/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.

Other adverse events

Other adverse events
Measure	Cohort 1 n=5 participants at risk C1: VN - plan to start OMB157 Vaccine naive, planning to start ofatumumab	Cohort 2 n=2 participants at risk C2: VN - on OMB157 \>=4 WKs Vaccine naive, currently on ofatumumab for ≥ 4 weeks	Cohort 3 C3: VN - INFy or GA \>=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks	Cohort 4 n=1 participants at risk C4: FV - OMB157 \>=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks	Cohort 5 n=11 participants at risk C5: FV - INFy or GA \>=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks	Cohort 6 n=5 participants at risk C6: FV - on OMB157 \>=4 WKs + booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, \+ booster
Ear and labyrinth disorders Ear discomfort	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Ear and labyrinth disorders Vertigo	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Eye disorders Eye inflammation	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Eye disorders Eye pain	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Eye disorders Retinal detachment	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Gastrointestinal disorders Nausea	40.0% 2/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
General disorders Chills	40.0% 2/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
General disorders Fatigue	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
General disorders Pain	40.0% 2/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
General disorders Pyrexia	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Infections and infestations COVID-19	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	18.2% 2/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Infections and infestations Fungal infection	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	9.1% 1/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Infections and infestations Influenza	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	40.0% 2/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Infections and infestations Vulvovaginal mycotic infection	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Investigations Blood pressure increased	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Investigations Influenza A virus test positive	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Investigations SARS-CoV-2 test positive	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Muscle discomfort	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Nervous system disorders Headache	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	50.0% 1/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Nervous system disorders Radiculopathy	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	9.1% 1/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Renal and urinary disorders Bladder spasm	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
Respiratory, thoracic and mediastinal disorders Sinus congestion	20.0% 1/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/2 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	— 0/0 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/1 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/11 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.	0.00% 0/5 • Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days. Cohorts 2 and 4 have been combined as participants were on ofatumumab \>4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for \>4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER